Market access strategy
Why is it that so many new products have failed to gain access in key markets over the past few years? Indeed, this is a question being asked of the main boards of pharmaceutical companies by their shareholders. Senior management teams are coming under increasing scrutiny and pressure from shareholders to reduce the number of products that fail to gain Health Technology Assessment (HTA) support and reimbursement approval in major markets. When analysing the reasons for these market failures, a number of strategic errors become evident. In large part, these errors stem from companies failing to have a clear strategy for market access in place from early Phase II development.
Why do companies need to focus on market access so early in the process?
The answer is relatively simple. Without a clear market access strategy locked in from Phase II, return on investment and profitability are significantly jeopardised.
Any company without an early strategy in place for a product’s development is likely to run major risks in the following areas.
“…these errors stem from companies failing to have a clear strategy for market access in place from early Phase II development.”
• Investing in products based only on the company’s own internal definitions of medical need.
• Investing in inappropriate clinical trial designs based on their use in the past.
• Investing in large population disease groups, rather than in smaller, well-defined sub-populations.
Furthermore, investing in health economic studies that are not specific to a defined market or patient group is a waste of resources. It is not unusual to see health economic studies that are largely academic in nature and fail to satisfy payers’ needs.
Selecting trial comparators internally to suit ease of comparison is also a waste of resource and can completely jeopardise the market access strategy.
In short, a detailed knowledge of target markets and of the treatment of relevant disease sub-groups is necessary to enable selection of appropriate patient populations for the product. Then, innovative trial designs and appropriate comparator- or market-specific studies will not only enable extensive and rapid market access, but also establish a position that other companies are unlikely to challenge. And so it is essential to bring the needs of the market place and its multiple stakeholders into the company at the earliest possible stage.
It’s true that regulatory experts within some companies are now considering the need for an overall approach to data generation that will meet both drug registration and market access requirements, i.e. generating market access datasets throughout the clinical development programme. However, many companies fail to address market access requirements until midway through their Phase III studies or, more often, after submission of the registration package.
And yet it is difficult to see why bringing the market needs into the company at the early stage is seen as anything other than a significant win – win situation. Resistance can only be down to a fear of change. Yes, current practices will change to a greater or lesser degree and, yes, traditional internal precepts will be replaced with new, validated requirements. Yes, the medical and marketing functions will need to become one group, which will require that certain staff adapt or be replaced. Others will need to learn new ways of working. But brave is the company that does not embrace such new ways of working and risks incurring the wrath of its shareholders.
“…investing in health economic studies that are not specific to a defined market or patient group is a waste of resources.”
There are many commercial agencies offering market access ‘solutions’ that differ according to each agency’s particular strength and focus. In fact the term market access has been hijacked by many whose expertise actually covers only limited elements of the total process, perhaps dossier construction or price and reimbursement planning. This prompts companies to select and outsource these components, adopting a “mix and match” approach that misses the overriding need to put a market access strategy in place from early phase II.
The best approach is to ensure that a dedicated internal resource is in place to devise the market access strategy before bringing in external agencies at the appropriate time to provide their input, using the right data towards a specific market focus.
So, how do you start to create a market access strategy? By first compiling a database of everything there is to know about your target disease and its treatment. And while that is easy to say, much care needs to be taken to avoid pitfalls along the way. For example, be wary of how you use input from opinion leaders. They may practice the ‘state of the art’ or know what it is, but often they themselves are clinical investigators, involved in one or more studies. Instead, the busy clinicians who see large numbers of patients in their practices are the ones you need to involve yourselves with. Aim to identify and quantify variations in clinical practice, rather than seeking and accepting consensus views.
If outsourcing this aspect be aware that specialists in this kind of work are rare. Generalists who can carry out a ‘market research study’ are commonplace, yet many do not have access to pharma-experienced medical and marketing experts to undertake the work. Beware the questionnaire approach, which may provide well-documented and consistent information while contributing little true insight or added value to your knowledge base.
This article serves only to set out the initial activity and knowledge gathering required. There is, of course, need for a comprehensive programme of phase- and time-specific activities required leading first to national, then regional and finally local market adoption. In addition, a process of continual monitoring must be built into this scheme, in order to ensure validation of each step along the path and to incorporate any changes that become necessary.
In Europe, reimbursement practices are going to change as a result of ongoing discussions within the European Commission. For one thing, time to reimbursement is set to come down to 120 days. This is in distinct contrast to the time frame for assessment adopted by the National Institute for Health and Clinical Excellence (NICE). While officially set at 301 days, in practice this can extend beyond 700 days.
“…the term market access has been hijacked by many whose expertise actually covers only limited elements of the total process…”
Then there is Spain, another of Europe’s key pharma markets, with 17 autonomous regions to consider. Spain will struggle to complete the necessary work across all regions in time to meet the new 120-day requirement.
Other policy changes under consideration include a move in England to a Value Based Pricing process in place of the current profit return-based approach.
This ever-changing regulatory landscape requires companies to continuously monitor health policies and keep abreast of changes in their target markets. Only then can they ensure that their market access strategy is dynamic, responsive to change and remains valid along the way.
About the authors:
Brian Lovatt was the primary author on this article. Brian Lovatt is an expert in market access strategy with extensive experience in both pharmaceutical development and international marketing. He became the first International industry-specific health economist, initiating an international pricing and reimbursement strategy within ICI pharmaceuticals / Zeneca over 20 years ago.
Brian also has specialised knowledge of Rare Diseases and orphan drug legislation in the EU.
Alan Wilkinson assisted in writing this article. Alan is an independent information professional specialising in pharmaceuticals and biotech. Throughout the last 10 years, Alan and Brian have collaborated on numerous projects focusing on market access strategy for pharmaceutical clients. As well as having extensive experience in western markets, Alan and Brian have also worked together on market access strategies for the Japanese pharma market.
They can be contacted via firstname.lastname@example.org or on +44 (0)75 1588 2926
How can you ensure that your market access strategy is dynamic and whilst remaining valid?